Navigating the Networks
Chantal Sunter
July 2014
Aims of today:
1. NIHR CRN Networks
a) Then, Now & the Future
b) Accessing Support
2. AcoRD Guidance & Costings
3. Questions
What is the NIHR CRN
NIHR Clinical Research Network (NIHR CRN) is the clinical
research delivery arm of the NHS in England
NHS CRN provide support to several thousand studies in
the NHS every year – a large proportion of the research
that takes place
Journey so far…
NIHR Clinical Research Network (NIHR CRN) is the clinical research
delivery arm of the NHS in England
Original Aims of the Networks
1
2
Increase the number of high quality studies
Increase the number of participants recruited
to those studies (Double in 5 years)
3
Support swift set up of studies including ID of
additional sites
Support recruitment into those studies by
engaging clinical teams
Ensure studies recruit to time and target
Support PPI involvement
Commercial studies
4
5
6
7
Patient Recruitment* (2013/14)
*England wide
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Recruitment milestone
This is the fourth consecutive year that the Network has surpassed its target to recruit
500,000 patients per year to clinical studies
The Network has recruited more than three million patients to clinical studies in the last six
years
Nearly 96,000 of these patients were recruited to commercial contract studies
NHS engagement
• The proportion of research-active Trusts recruiting
patients onto NIHR CRN Portfolio studies remains high
at over 99%
• The number of Trusts engaged in commercial contract
clinical research is increasing year on year. 86% of
Trusts now recruit patients onto NIHR CRN Portfolio
commercial contract studies
• Future challenge – Any Qualified Providers (AWP’s)
NIHR CRN Portfolio
2013/14 England wide
Study set-up
2013/14 England wide
Study Delivery
2013/14 England wide
Supporting Industry
2013/14 England wide
Summary so far
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•
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Trends show that the environment for delivery of clinical studies in the NHS in
England is improving
There is widespread engagement amongst healthcare providers
Patient recruitment is up
Study set-up times are down
•
The Network is not complacent – still driving performance improvements across all
parts of the service
•
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Inconsistent geographical coverage
102 local research networks  Duplication  increase in hosting costs, finance, HR
etc
Inconsistencies in support available
•
Time for Change
Transition is a product of our
success, it is important that we
change to ensure we can
continue to deliver clinical
research to make patients, and
the NHS, better
Evolution not Revolution
Why Transition?
Transition Programme Benefit
1
Equality of access to research for patients
2
Embedding of research into the new health and social care
structures
3
Enhanced engagement within the NHS and the life-sciences sector
4
Increased efficiency through reduced transaction costs and
increased productivity
5
Transparent, consistent governance and clear accountability
6
Improved flexibility and responsive research delivery
7
Improved staff retention and career development
Benefits of Evolution
What Will Change?
Hosting
Geographical
coverage
Resource
coordination
Organisational
structures
Where are we now?
Where are we moving to?
9 NIHR CRN Network Coordinating
Centres with 7 individual hosting
agreements
1 NIHR CRN Coordinating Centre
(incorporating clinical thematic leadership) with
1 hosting agreement
102 NIHR CRN comprehensive/local
research networks with 102 individual
hosting agreements with 70 hosts
15 Local NIHR CRN research networks
(integrated) with 14 individual hosting
agreements with 14 hosts (ie, 1 each)
Inconsistent national coverage for
research into key therapy areas
Full national coverage for research into all key
therapy areas
Complex geographical configuration
Simplified geographical configuration
Dispersed model of workforce
coordination
Single model of workforce coordination,
responsive to local need
Dispersed and fragmented oversight of
deployment of resources
Strategic oversight for the deployment of
resources at national / local partner level
Inconsistent models of funding
allocation/use
Consistent models of funding allocation/use
Complex organisational structure
Streamlined organisational structure
Inconsistent models of clinical leadership
across networks
Consistent model of clinical leadership across
networks
Partner organisations receiving multiple
and confusing funding streams
Partner organisations receiving single
coordinated funding stream
INTEGRATING THE NETWORKS
• 2 x Cancer
• 1 x Mental Health
• 2 x Diabetes (partial
coverage)
• 1 x Stroke (partial coverage)
• 1 x Primary Care
• 1 x Medicines for
Children
• 1 x DeNDRoN
• 1 x CLRN
SPECIALTIES, THEMES & RESEARCH DELIVERY
DIVISIONS:
CLINICAL DIVISIONS:
Division
1
2
Specialties in this division
Cancer
3
Children, genetics, haematology, reproductive health and childbirth
4
Dementias and neurodegeneration (DeNDRoN), mental health,
neurological disorders
5
Primary care, ageing, health services and delivery research, oral
health and dentistry, public health, musculoskeletal disorders,
dermatology
6
Anaesthesia/peri-operative medicine and pain management, critical
care, injuries/emergencies, surgery, ENT, infectious
diseases/microbiology, opthalmology, respiratory disorders,
gastroenterology, hepatology
Diabetes, stroke, cardiovascular disease metabolic and endocrine
disorders, renal disorders
Management & Leadership Structure
Clinical Director
(Dr Stephen Falk)
Chief Operating
Officer
(Dr Mary Perkins)
Nurse Consultant
(Dr Sue Taylor)
Senior Research Delivery
Manager – Cross Cutting
(Martine Cross)
Industry Operations
Manager
(Acting - Holly Valance)
LCRN Research
Delivery Cross –
Cutting Team
Senior Research
Delivery Manager:
(Maxine Taylor, Div 1&3)
Research Delivery
Manager
(TBA - Div 2&4)
Research Delivery
Manager
(Chantal Sunter,
Div 4&5)
Research Delivery Divisions:
 Operational delivery of the LCRN portfolio managed through
six nationally determined research delivery divisions, each
encompassing a number of specialties
 Managed by a Research Delivery Manager, each Manager
will form national networks of operational expertise, led
nationally by a Research Delivery Director for the Division
 LCRN Research Delivery Managers will report to the LCRN
Chief Operating Officer and be responsible for the delivery
of NIHR CRN portfolio studies
LCRN Support Team:
 The LCRN will have a Support Team to manage local
operational arrangements. This team will be required to
support and deliver the following functions and systems:
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Support functions including (some of these functions may
be encompassed within research delivery roles):
 LCRN administration
 Information management
 Workforce development
 Communications
 Patient carer and public involvement and engagement
 Finance
CRN systems, including information systems (for example,
the CSP Module for NHS Permissions, CPMS and LPMS)
Research Delivery
Cross-Divisional Team
 Research Delivery Cross-Divisional Team will undertake
delivery activities that support all clinical specialties.
Activities will include the provision of:
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A LCRN research advice service
A single point of contact service for Life Sciences Industry
A Lead LCRN service and Coordinated Network Support
service, in-line with national standards
The NIHR Coordinated system for gaining NHS
Permission (CSP)
Coordination of the Research Passport Scheme
What is staying the same?
• Evolution not revolution
• Delivery staff (Research Nurses, Clinical Studies
Officers)
• Fewer issues around crossing boundaries e.g. mental
health staff working in primary care settings or AHP’s on
mental health related studies
• Contact your relevant RDM or usual Lead Research
Nurse / Senior CSO if looking for study support
• RDM’s working closely with R&D offices across the
region
• Involve the network at early stage as possible
Patient and Public Involvement
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PPI / PI / PCPIE / Service User Involvement
Cross organisation approach and team
Retaining specialty groups where appropriate
ClahrcWest / WEAHSN / CRN WE / HPU
Strategy group:
8 public members (2 sit on each organisation)
4 organisational members
• Develop and agree strategies on common issues e.g.
payment
PPI (Division 4)
• Currently still a dedicated PPI worker 0.4wte
• Some initiatives looking to roll out across specialties:
Pre-ethics materials review service
Exit questionnaire
Everyone Included
AcoRD
• Attribution of COsts of Research & Development
• Formerly known as ARCO
Major aim to
• Improve the consistency of cost attribution
• Encourage more consistent funding of the costs of
research
(Research Costs, Excess Treatment Costs, Service
Support Costs)
Major Changes
• Guidance aims to clarify / correctly attribute R&D costs
to either ETC, SSC or research costs
• ARCO classified on the basis of WHO was carrying out
the activity
• AcoRD classifies on the basis of the PRIMARY
PURPOSE of the activity.
• Pilot of a new Costing template ACAT (Activity Capture
Attribution Template) for use with full grant applications
• Taking consent is classified as SSC not research cost
• 2 different categories of research costs (Depends on
funder)
AcoRD continued
Network Delivery Funding is Service Support Costs = early
engagement important
Currently will primarily impact AMRC funders (even when
only part of the grant funding is from AMRC)
Full application stage will require ACAT completion with the
application (funders will inform applicants if / when
required)
Likely to be rolled out to all funders eventually
ACAT support
•
AcoRD Specialists in each Clinical Research Network
•
You will be informed if you are required to complete the ACAT and who your
local specialists are.
•
They will provide support in completing the ACAT (but wont complete it for
you)
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The completed ACAT will then be reviewed by additional ACAT reviewers
following submission to funder
•
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Suite of support materials available at
http://www.crn.nihr.ac.uk/can-help/funders-academics/support-for-noncommercial-studies/acord/
Thank you for listening
Questions?
Chantal.sunter@nihr.ac.uk